Off Script: A Pharma Manufacturing Podcast

FDA approves Adaptimmune therapy, halts vTv diabetes program; Sanofi sues Sarepta over Duchenne patents [The good, the bad, the ugly]

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  

The good — FDA approves Adaptimmune engineered cell therapy 
The bad — FDA puts clinical hold on vTv Therapeutics diabetes program 
The ugly — Sanofi sues Sarepta over manufacturing patents for Duchenne gene therapy 

FDA approves Sun Pharma hair loss drug, FDA issues warning letter to Brassica, EMA rejects Eisai-Biogen Alzheimer's drug [The good, the bad, the ugly]

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  

The good — FDA approves Sun Pharma hair loss drug 
The bad — FDA issues harsh warning letter to Indian CDMO Brassica 
The ugly — EMA issues negative opinion on Eisai-Biogen Alzheimer's drug 

Genentech's oral weight loss drug shows promise; FDA denies accelerated approval for Agenus' cancer drug; Orexo's opioid overdose drug rejected again [The good, the bad, the ugly]

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  

The good — Genentech's oral weight loss drug shows promise 
The bad — FDA denies accelerated approval for Agenus' cancer drug 
The ugly — Orexo's opioid overdose drug rejected again 

Pfizer advances obesity pill, FDA rejects Novo insulin, FTC releases PBM report [The good, the bad, the ugly]

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  

The good — Pfizer advances once-daily obesity pill 
The bad — FDA rejects Novo Nordisk once-weekly insulin 
The ugly — FTC releases long-awaited report on PBMs 

Lilly Alzheimer’s drug gets full approval, Rocket gene therapy rejected, Eisai, BMS end ADC partnership [The good, the bad, the ugly]

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  

The good — FDA grants Eli Lilly Alzheimer’s drug full approval 
The bad — FDA rejects Rocket gene therapy 
The ugly — Eisai, BMS end ADC partnership 

[Solutions Spotlight] Streamlining oral dose packaging design

By integrating a Quality by Design (QbD) approach, developers can design robust packaging from the outset,  drastically reducing development time and costs. Understanding how moisture affects a product is key, allowing developers to use industry-accepted and validated models to predict and address potential stability issues early in the design phase, thereby reducing the need for prolonged probe stability testing and potential reformulations or packaging redesign. 

To understand more about the issues at hand, senior editor Andrea Corona recently spoke with Adrian Possumato, president and Chris Gilmor, director of sales, at Sanner of America.

Learn more about Sanner of America: https://www.sanner-group.com/

 

Verona wins COPD nod, FDA rejects Merck-Daiichi ADC, Glenmark recalls potassium chloride capsules [The good, the bad, the ugly]

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  

The good — Verona wins FDA nod for COPD 
The bad — FDA issues CRL to Merck-Daiichi lung cancer ADC 
The ugly — Glenmark recalls 114 batches of potassium chloride capsules 

Gilead HIV shot delivers zero infections, Takeda epilepsy drug misses endpoints, Lilly goes after counterfeiters [The good, the bad, the ugly]

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: 

The good — Gilead twice-yearly HIV shot delivers zero infections in trial 
The bad — Takeda epilepsy drug misses endpoints in trials 
The ugly — Eli Lilly goes after counterfeiters 

FDA backs Lilly Alzheimer’s drug; Pfizer Duchenne gene therapy fails; Talc plaintiffs seek J&J bankruptcy restraining order [The good, the bad, the ugly]

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: 

The good — FDA AdComm backs Eli Lilly Alzheimer’s drug
The bad — Pfizer gene therapy fails phase 3 Duchenne trial
The ugly — Talc plaintiffs seek restraining order on J&J bankruptcy tactic

AZ's Tagrisso shines in phase 3 trial, BMS layoffs, FDA violations at Jiangsu Hengrui site [The good, the bad, the ugly]

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: 

The good —  AstraZeneca’s Tagrisso delivers 84% progression-free survival in trial
The bad — BMS to let go of 863 employees at NJ site 
The ugly — FDA inspection uncovers multiple violations at Jiangsu Hengrui Pharmaceuticals site